Below you will find information about planned research on cervical barriers and internal/female condoms.
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Non-comparative study of the contraceptive efficacy of the Cupid female condom
Location: South Africa
Purpose: To assess the effectiveness of the female condom (FC) for the prevention of pregnancy among women choosing the Cupid female condom as their method of fertility regulation
Design: A non-comparative, prospective follow-up study. The volunteers will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage. The primary endpoint will be the occurrence of pregnancy or use of emergency contraception, and the diary information will allow pregnancy rates to be characterised by patterns of condom use and failures (contraceptive efficacy and effectiveness rates).
Population: The target population will be 250 urban and peri urban, sexually-active women who are experienced users of FCs. Recruitment will be from a large family planning clinic associated with the MatCH Research Unit (MRU), University of the Witwatersrand, Durban, South Africa.
Study duration: 18 months
Primary objective: To evaluate contraceptive efficacy as the Cupid FC as the primary method of contraception.
- To estimate the relative importance of contraceptive method failure (efficacy) and user failure (effectiveness) to the overall contraceptive failure rate as measured by the occurrence of pregnancy, requests for emergency contraception (EC), or both. EC will be used as a surrogate marker for perceived user or method failure. Efficacy is assessed by the pregnancy rate under condition of perfect use of the device while effectiveness is measured by the overall pregnancy rate, and includes pregnancies occurring when the device was not used or was used correctly.
- To determine the continuation rate at six months of use of the female condom
Study site: MRU, University of the Witwatersrand, Durban, South Africa.
This study will commence in May 2019.